Dihydroartemisinin-piperaquine and Primaquine for Uncomplicated Plasmodium Falciparum Cases

Malaria Clinical Trial

— DHP+PQ  

Official title:

Effectiveness of Dihydroartemisinin-piperaquine With or Without Primaquine on Gametocytes Plasmodium Falciparum in Mesoendemic Area of Indonesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392014
• Other study ID #: 45114
• Secondary ID: 45114
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2011
• Last updated: July 8, 2011
• Start date: December 2008
• Est. completion date: October 2010

Study information

• Verified date: August 2008
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Interventional

Clinical Trial Summary

Artemisinin-based combination therapy (ACT) has been known to be controversial for stopping malaria transmission.The addition of primaquine (PQ) - the only drug commercially available that kills mature transmission stage - to such treatments might be necessary to eliminate this stage. A study is conducted to evaluate the efficacy of dihydroartemisinin-piperaquine (DHP) regimens with or without PQ on the sexual and asexual stages of P. falciparum in Sumatra, Indonesia.

Description:

The study was conducted in Hanura Primary Health Center, Padang Cermin district, Lampung province (105°45'-103°48'E and 3°45'-6°45'S) located at the southern end of Sumatra island.

The study subjects received either 3 day doses of dihydroartemisinin-piperaquine with or without 1 day of primaquine according to their body weight.

Patients with fever or history of fever within the past 24 hours were screened by microscopic examination of Giemsa-stained thick blood films to detect P. falciparum infection.

All subjects were allocated by open-label randomization to receive DHP alone (on Day 0 to Day 2) or DHP plus a single dose of PQ (Day 3). The procedures of drug administration in the study were as follows:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: October 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

Inclusion Criteria:

• age = 4 years old

• parasite count = 1,000 asexual parasites/µL

• normal glucose-6-phosphate dehydrogenase enzyme level based on qualitative test (Trinity Biotech® no 203, USA)

• hemoglobin level = 8 gr/dL as measured by Hemoque® apparatus;

• have the ability to return for 42-day-follow up and

• willingness to sign the informed-consent form.

Exclusion Criteria:

• are infected with other r plasmodium species

• have only gametocytes of P. falciparum;

• are pregnant - measured by positive result on HCG urine test and/or breastfeeding women

• present signs of pitting edema on both legs as a sign of malnutrition

• have complicated or severe malaria, other chronic diseases or history of drug allergies.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• dihydroartemisinin-piperaquine
This study used fixed-dose tablets of 40 mg dihydroartemisinin and 320 mg piperaquine for each tablet (D-ARTEPP®, Guilin Pharmaceutical Co., Ltd, China. The regimen is based on weight for 3 days (D0, D1 and D2) with maximal dose of 1 x 3 tablets for patients weighing = 41 kg; 1 x 2 tablets for patients weighing 31 - 40 kg, 1 x 1.5 tablets for patients weighing 18 - 30 kg, and 1 X 1 tablet for patients with body weight of 11 - 17 kg.
• dihydroartemisinin-piperaquine + primaquine
For DHP, treatment was as for Arm dihydroartemisinin piperaquine. A single dose PQ of 0.75 mg/kg BW was provided on Day-3 using 15 mg base PQ tablets (local product by PT Pharos Indonesia, batch no 15306002, produced on 30/05/2008 and expiring on May 2012). The maximal dose was 3 tablets for subjects weighing = 60 kg. The dose range for subjects weighing 10 - 13 kg was 0.5 tablet; 14 - 18 kg was 0.75 tablet; 19 - 23 kg was 1 tablet, 24 -30 kg was 1.5 tablet; 31 - 40 kg was 2 tablets; 41- 49 kg was 2.25 tablet; 50 - 59 kg was 2.5 tablet and = 60 kg was 3 tablets.

Locations

Country	Name	City	State
Indonesia	Hanura Primary Health Center	Lampung	Sumatra

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of sexual stages of P.falciparum	Finger prick blood samples are collected for malaria blood smear. Thick and thin blood smears were stained with 3% Giemsa solution for 40 minutes and were read under binocular microscope with 1,000X magnification.	42 days post treatment	Yes
Secondary	Clearance of asexual stages P.falciparum	Finger prick blood samples are collected for malaria blood smear. Thick and thin blood smears were stained with 3% Giemsa solution for 40 minutes and were read under binocular microscope with 1,000X magnification.	42 days post treatment	Yes